Design Options® 530185Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955625147), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0125-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: ISSUE: LOSS OF RESISTANCE OBTAINED AT 9CM VIA 17G TUOHY NEEDLE. 19G SPRINGWOUND CATHETER WOULD NOT ADVANCE PAST 11CM (THEREFORE DID NOT ADVANCE PAST TUOHY TIP) AND THEN WOULD NOT RETRACT. AFTER MULTIPLE ATTEMPTS AT REMOVAL OF THE CATHETER FROM THE TUOHY, IT CAME OUT WITH THE BLUE TIP FRAGMENTED OFF. THE FRAGMENT WAS LATER FOUND ON IMAGING TO BE AT L5-S1 EPIDURAL SPACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20370996 ↗